BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3882466 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-85928
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS AND ONLY HAS PHYSICAL DAMAGE AS THE LCD WINDOW IS SCRATCHED AND THE RESERVOIR TUBE LIP CRACKED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER STATED HIS BLOOD GLUCOSE LEVELS WERE ABOVE 500MG/DL FOR THE THREE PREVIOUS DAYS AND WAS 407MG/DL WHEN ADMITTED AT THE HOSPITAL. HE CONFIRMED HE WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EVENT AND IS BEING TREATED WITH INTRAVENOUS INSULIN DRIP AND MANUAL INJECTIONS. INSULIN PUMP WAS REPLACED AS PER CUSTOMER'S REQUEST. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357225 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization